Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon… (NCT02777437) | Clinical Trial Compass
UnknownPhase 2/3
Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer
1,960 participantsStarted 2016-10
Plain-language summary
Primary Outcome Measures: Disease free survival
Secondary Outcome Measures:
Overall survival
Adverse events (Mortality, morbidity)
The proportion of completion of Laparoscopic Surgery
Estimated Enrollment: Oct, 2016
Study Start Date: Oct, 2016
Estimated Study Completion Date: Oct, 2019
Estimated Primary Completion Date: Oct, 2021
Groups/Cohorts
1. Laparoscopic surgery for T4 colon cancers
2. Neoadjuvantive chemotherapy + Laparoscopic surgery for T4 colon cancers
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Able to provide written informed consent
* Histologically confirmed diagnosis of colon carcinoma
* CT or MRI verified as T4 colon cancer without involvement of other organs.
* Without multiple lesions other than carcinoma in situ
* Tumor size \< 8 cm
* No bowel obstruction
* Sufficient organ function
* No history of gastrointestinal surgery
* 18 years of age or older
* Performance Status (ECOG) 0, 1 or 2, life expectancy \> 12 weeks
* Operable patients
* Completion of neoadjuvant systemic chemotherapy
Exclusion Criteria:
* Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding
* No intention to finish neoadjuvantive systemic therapy
* Unstable or uncompensated respiratory or cardiac disease
* Serious active infections
* Hypersensitivity to capecitabine/fluorouracil or oxaliplatin
* Stomatitis or ulceration in the mouth or gastrointestinal tract
* Severe diarrhea
* Peripheral sensory neuropathy with functional impairment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.